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Prevalence of Ocular Surface Disease among Glaucoma Patients Receiving Topical Antiglaucoma Therapy at Al Jawarih Eye Hospital, Dongola, Sudan: A cross-Sectional Study (2026)

ETH-20260407-0149 تاريخ التقديم: Apr 07, 2026 / Submitted: Apr 07, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
أبحاث طبية / Medical Research
فترة الدراسة / Study Period
Apr 10, 2026 - Dec 10, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
---
Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
---
رقم التسلسل
Serial Number
SER-20260407-0149
رقم الطلب
Request Number
ETH-20260407-0149
تاريخ تقديم الطلب
Date of Submission
2026-04-07

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Nosiba Mohammed Khoajali Ballah
2. الجهة التي ينتمي إليها
Affiliation Type
مؤسسة / Institution
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
nosiba491@gmail.com
5. رقم الهاتف
Phone Number
00249914716506
المشرف / Supervisor
الاسم الكامل / Full Name
-
البريد الإلكتروني / Email
nosiba491@gmail.com
الوظيفة / اللقب العلمي / Job Title
-
رقم الهاتف / Phone
-
القسم / المؤسسة / Department
-

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Prevalence of Ocular Surface Disease among Glaucoma Patients Receiving Topical Antiglaucoma Therapy at Al Jawarih Eye Hospital, Dongola, Sudan: A cross-Sectional Study (2026)
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☐بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☐ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☑أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
# **Prevalence of Ocular Surface Disease among Glaucoma Patients Receiving Topical Antiglaucoma Therapy at Al Jawarih Eye Hospital, Dongola, Sudan: A cross-Sectional Study (2026)** --- ## **Introduction** Glaucoma is a progressive optic neuropathy and a leading cause of irreversible blindness. Lifelong topical therapy is required to lower intraocular pressure (IOP). Chronic use, especially of **preservative-containing drops (BAK)**, is associated with **ocular surface disease (OSD)**—causing dryness, irritation, and reduced quality of life, which can affect medication adherence and surgical outcomes. --- ## **Literature Review** * OSD prevalence in glaucoma patients: 40–60% (Leung 2008, Fechtner 2010) * Severity correlates with **number of medications** and **duration of therapy** * Preservatives are major contributors to epithelial and inflammatory damage * Local data in Sudan are limited --- ## **Problem Statement** There is no local evidence on OSD prevalence among glaucoma patients in tertiary clinics, making it difficult to guide therapy, especially regarding preservative-free options. --- ## **Objectives** **General:** Determine prevalence of OSD in glaucoma patients on topical therapy **Specific:** * Assess severity via OSDI * Correlate severity with number/type of medications and therapy duration --- ## **Methodology** * **Design:** Descriptive hospital-based cross-sectional * **Period:** April–July 2026 * **Population:** Glaucoma patients ≥18 years on topical therapy ≥3 months * **Sample:** 230 patients (systematic sampling) * **Data Collection:** Demographics, OSDI questionnaire, TBUT, corneal fluorescein staining * **OSD Definition:** OSDI ≥13, TBUT <10s, or corneal staining * **Analysis:** SPSS 25; descriptive and inferential statistics --- ## **Ethical Considerations** * IRB approval * Informed consent * Right to withdraw * Privacy and confidentiality ensured

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☑شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
collect only necessary data, anonymize/pseudonymize it, store and transmit securely, limit access, get consent, de-identify results, and follow laws/regulations.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
Access to new treatments or interventions Contribution to scientific knowledge and society Personal health insights or screenings Learning about the condition or research process Feeling empowered by contributing to change Possible financial or material compensation
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Nosiba Mohammed Khoajali Ballah
التوقيع / Signature
_______________________
التاريخ / Date
2026-04-07

معلومات الباحث / Researcher Information

N

Nosiba Mohammed Khoajali Ballah

nosiba491@gmail.com

00249914716506

Al_Jawarih Eye Hospital

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

Dongola, Ansar Alsunah, North state

معلومات الدراسة / Study Information

أبحاث طبية / Medical Research

messages.degree_medical_research - messages.degree_medical_research

21,000.00 SDG

# **Prevalence of Ocular Surface Disease among Glaucoma Patients Receiving Topical Antiglaucoma Therapy at Al Jawarih Eye Hospital, Dongola, Sudan: A cross-Sectional Study (2026)** --- ## **Introduction** Glaucoma is a progressive optic neuropathy and a leading cause of irreversible blindness. Lifelong topical therapy is required to lower intraocular pressure (IOP). Chronic use, especially of **preservative-containing drops (BAK)**, is associated with **ocular surface disease (OSD)**—causing dryness, irritation, and reduced quality of life, which can affect medication adherence and surgical outcomes. --- ## **Literature Review** * OSD prevalence in glaucoma patients: 40–60% (Leung 2008, Fechtner 2010) * Severity correlates with **number of medications** and **duration of therapy** * Preservatives are major contributors to epithelial and inflammatory damage * Local data in Sudan are limited --- ## **Problem Statement** There is no local evidence on OSD prevalence among glaucoma patients in tertiary clinics, making it difficult to guide therapy, especially regarding preservative-free options. --- ## **Objectives** **General:** Determine prevalence of OSD in glaucoma patients on topical therapy **Specific:** * Assess severity via OSDI * Correlate severity with number/type of medications and therapy duration --- ## **Methodology** * **Design:** Descriptive hospital-based cross-sectional * **Period:** April–July 2026 * **Population:** Glaucoma patients ≥18 years on topical therapy ≥3 months * **Sample:** 230 patients (systematic sampling) * **Data Collection:** Demographics, OSDI questionnaire, TBUT, corneal fluorescein staining * **OSD Definition:** OSDI ≥13, TBUT <10s, or corneal staining * **Analysis:** SPSS 25; descriptive and inferential statistics --- ## **Ethical Considerations** * IRB approval * Informed consent * Right to withdraw * Privacy and confidentiality ensured

Apr 10, 2026 - Dec 10, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر منخفضة - Low Risk

collect only necessary data, anonymize/pseudonymize it, store and transmit securely, limit access, get consent, de-identify results, and follow laws/regulations.

Access to new treatments or interventions Contribution to scientific knowledge and society Personal health insights or screenings Learning about the condition or research process Feeling empowered by contributing to change Possible financial or material compensation

Elderly